Log in
RegisterFailure of BE in fasting studies [Study Assessment]
Dear drsinghs
If the replicate design and the 2 way crossover have the same power and the same intra-subject variability then these two studies will have the same chance to pass (or fail). In your case (same formulations) it solely depends on sample size:
For a given intra-subject CV of for example 20.0 % you need in a full replicate design 10 subjects, in a half replicate dasign 16 subjects and in a 2 way crossover design 20 subjects to show bioequivalence in the general acceptance range of 80 - 125% with a power of more than 80% each.
I hope this helps
Kind regards
Dan
❝ Is it possible that a formulation will pass in replicate design and same will fail in 2 way crossover?
❝
❝ What impact will be on ratio and 90% CI, If I test same formulation in 2 way crossover and replicate design?
If the replicate design and the 2 way crossover have the same power and the same intra-subject variability then these two studies will have the same chance to pass (or fail). In your case (same formulations) it solely depends on sample size:
- Theta (%): the target ratio in average BA between the two formulations expressed in percentage of the average reference BA.
- Power (%): the least statistical power to detect (1-Power) differences between the Test and the Reference formulation.
- CV (%): the intra-subject coefficient of variation for crossover(or replicate crossover) study.
- Lower acceptance limit represents the lower BE criteria to be accepted;
the upper acceptance limit is equal to 1/(lower acceptance limit). Usually the lower limit can be 80.000% or, 70.000% in some cases.
Upper acceptance limit = 125 %
Lower acceptance limit = 80 %
Expected ratio T/R = 95.00 %
Target power = 80.00 %
Intra-subject CV = 20.0 %
study 2x2x2 2x2x3 2x2x4
design crossover replicated replicated
------- ----------- ------------ ------------
N 20 16 10
Estimated power = 83.46802 %For a given intra-subject CV of for example 20.0 % you need in a full replicate design 10 subjects, in a half replicate dasign 16 subjects and in a 2 way crossover design 20 subjects to show bioequivalence in the general acceptance range of 80 - 125% with a power of more than 80% each.
I hope this helps
Kind regards
Dan
—
Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Failure of BE in fasting studies ABE1580 2012-10-09 15:42
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Failure of BE in fasting studies drgunasakaran1 2012-10-09 20:07
- Failure of BE in fasting studies cakhatri 2012-10-10 07:34
- Failure of BE in fasting studies Dr_Dan 2012-10-10 13:09
- Different designs: why not? Helmut 2012-10-10 13:48
- Different designs: why not? cakhatri 2012-10-12 10:42
- Failure of BE in fasting studies drgunasakaran1 2012-10-10 19:14
- Failure of BE in fasting studies ABE1580 2012-10-11 06:10
- Failure of BE in fasting studies drsinghs 2012-10-11 09:28
- Failure of BE in fasting studiesDr_Dan 2012-10-11 11:43
- 1–β not necessarily = Δ Helmut 2012-10-11 13:05
- Sample size d_labes 2012-10-11 13:10
- +partial replicate Helmut 2012-10-11 17:53
- Failure of BE in fasting studiesDr_Dan 2012-10-11 11:43
- Failure of BE in fasting studies cakhatri 2012-10-10 07:34
- Failure of BE in fasting studies drgunasakaran1 2012-10-09 20:07
Ing. Helmut Schütz